Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors

Conditions

Neoplasm Metastasis

Brief summary

PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.

Renaud Sabatier, Séverine Garnier, Arnaud Guillé, Nadine Carbuccia, Jihane Pakradouni et al. (14 authors)

Frontiers in Oncology2022-07-2915 citations

10.3389/fonc.2022.946257

Prospective high-throughput genome profiling of advanced cancers: results of the PERMED-01 clinical trial

François Bertucci, Anthony Gonçalvès, Arnaud Guillé, José Adélaı̈de, Séverine Garnier et al. (34 authors)

Genome Medicine2021-05-1853 citations

10.1186/s13073-021-00897-9

A major response to carboplatin in a metastatic triple-negative breast cancer patient with somatic mutation of BRCA1 and RAD51B: When chemotherapy meets precision medicine

Lorène Seguin, Max Chaffanet, Renaud Sabatier, Amparo Burgos-San José, S. Garnier et al. (10 authors)

Annals of Oncology2018-09-011 citations

10.1093/annonc/mdy314.030

Interventions

PROCEDUREbiopsy or surgical sampling

OTHERblood sampling

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Age\>18 years * Histological diagnosis of cancer * Locally advanced or metastatic, biopsiable disease * ECOG Performans Status ≤2 * Affiliation to social security * Signed informed consent.

Exclusion criteria

* Emergency, Individually deprived of liberty or placed under the authority of a tutor * Patients with symptomatic or progressive brain metastasis * Patients who have only bone and/or brain metastases * Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists	4-6 weeks after biopsy

Secondary

Measure	Time frame	Description
Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing	3.5 years	—
Full exome and transcriptome sequencingof locally advanced and metastatic tumours	6 years	—
Circulating tumor DNA detection and characterization in locally advanced and metastatic disease	4 years	—
Circulating Tumor Cells (CTC) detection and characterization in breast cancer	3.5 years	Comparison of three distinct methods for the CTC detection in blood
Preclinical predictive clinical models validation (limited to breast cancer)	4 years	Patient-derived tumour xenograft models (PDX), drug sensitivity tests in vitro

Countries

France

Outcome results

None listed